HEALTH RELATED QUALITY OF LIFE AND DEVICE-ACCEPTANCE IN PATIENTS WITH IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS AND TELEMONITORING
Florian Leppert, Johannes Siebermair, Stefan Kääb, Wolfgang Greiner
OBJECTIVES:
Telemedical systems (TMS) and data management for implantable cardioverter-defibrillators (ICD) promise to reduce costs and optimize patient care. Depressive symptoms are common among patients with an ICD and the health related quality of life (HRQoL) is affected by the underlying disease and the implanted device, respectively. TMS might improve the HRQoL of patients and ICDs acceptance due to a closer monitoring and, thereby, an increased level of perceived safety. In this study, changes in the level of depression, HRQoL and device acceptance over a period of six months after ICD-implantation were investigated.
METHODS:
In this randomized controlled trial, 161 (80.7% male; age: 64,1 ± 14,6; 82% with coronary disease, 11% with dilated cardiomyopathy) patients with an ICD were randomized at the day of implantation into intervention (n=82) or control group (n=79). Patients in the intervention group were equipped with a telemonitoring system that transferred device data (e.g. critical events, status of battery, heart function) from the patients’ home to the medical practitioner via internet. The control group received regular care. Patients were asked to fill out three questionnaires (the generic EQ-5D, the depression specific Hospital Anxiety and Depression Scale (HADS) and the device specific Florida Patient Acceptance Survey (FPAS)); the follow-up period was six month, with postal surveys on a monthly basis (7 times in total). Collected data were analyzed in a pseudonymized manner. Datasets with missing values were filled by applying the Expectation-Maximization (EM) method.
RESULTS:
Nine patients dropped out before survey completion at month six for different reasons (e.g. draw back consent or death). Of the remaining 152 patients 140 patients filled out at least two sets of questionnaires and were included in the analyses. After six months the mean improvement in the health related quality of life (EQ-5D-Index) in the telemonitoring group was 10.7 points compared to baseline (p=.006) while the mean change in HRQoL in the control group was 5.5 points (p=.138). FPAS and HADS-D showed small but non-significant advantage for the telemonitoring group concerning acceptance and level of depression, respectively.
CONCLUSIONS:
Preliminary results suggest that telemonitoring systems have the ability to improve the health related quality of life of patients with implantable cardioverter-defibrillators. Results on effects towards the level of depression and anxiety and the enhancement of ICDs acceptance are also promising. Since ICDs are used in chronic heart diseases a longer follow-up period seems to be required to validate the effects.